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The AMO WHITESTAR Signature Phacoemulsification System is a modular ophthalmic microsurgical system that facilitates anterior segment (i.e., cataract) ophthalmic surgery. The modular design allows the users to configure the system to meet their surgical requirements.

The subject device is the AMO WHITESTAR Signature Phacoemulsification System, which is an upgrade to the predicate device, The AMO Ophthalmic Surgical System (K060366, cleared in April 7, 2006). The predicate device is AMO's first-generation WHITESTAR Signature Phacoemulsification System. The subject device is classified under 21 CFR 886.4670 as a "phacofragmentation system," described as an AC-powered device with a fragmenting needle intended for use in cataract surgery to disrupt a cataract with ultrasound and extract the cataract.

The subject device is designed for use in performing anterior segment ophthalmic surgery (i.e., cataract). It is intended for use in performing phacoemulsification, diathermy. irrigation/aspiration, and vitrectomy. The system has a console for controlling the functions and powering the device; a display with a touch screen for selecting and activating functions: irrigation and aspiration lines; a foot pedal and remote controlling the device; an automated IV pole; a phacoemulsification handpiece for emulsifying the lens; and drainage packs. The materials, fundamental scientific technology, physical properties, and intended use of the subject device are identical to those of The AMO Ophthalmic Surgical System.

The provided text pertains to a 510(k) summary for the AMO WHITESTAR Signature Phacoemulsification System, which is an upgrade to a previously cleared device. The summary emphasizes substantial equivalence to the predicate device rather than presenting specific acceptance criteria and a study demonstrating performance against those criteria in the way one might see for a diagnostic AI device.

Therefore, many of the requested categories (such as sample size for test set, number of experts, adjudication method, AI assistance studies, ground truth details, training set size, etc.) are not applicable or not provided in this type of regulatory submission for this device.

Here's an analysis based on the available information:

1. A table of acceptance criteria and the reported device performance

The document does not specify quantitative "acceptance criteria" and "reported device performance" in the typical sense for a diagnostic device. Instead, the performance is assessed through substantial equivalence to a predicate device.

2. Sample size used for the test set and the data provenance

Not Applicable / Not Provided. This submission relies on non-clinical testing and comparison to a predicate device rather than a clinical trial with a "test set" of patient data for performance evaluation in a diagnostic context.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable / Not Provided. Ground truth establishment by experts is typically relevant for diagnostic device performance studies. This submission focuses on engineering and functional equivalence.

4. Adjudication method for the test set

Not Applicable / Not Provided. Adjudication methods are used in studies involving expert interpretation of data, which is not described here.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable / Not Provided. This device is a surgical system, not an AI-assisted diagnostic tool. Therefore, MRMC studies and AI assistance are not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable / Not Provided. This is a surgical device, not an algorithm.

7. The type of ground truth used

For this type of device, the "ground truth" for non-clinical testing would relate to engineering specifications, functional performance, and safety standards. The document states:

• "System validation and verification have demonstrated that the functional requirements and system specifications were met prior to commercial release."
• "The AMO WHITESTAR Signature Phacoemulsification System has undergone testing and is in compliance with the applicable requirements of safety standards."

8. The sample size for the training set

Not Applicable / Not Provided. The concept of a "training set" is relevant for machine learning algorithms, which is not this device.

9. How the ground truth for the training set was established

Not Applicable / Not Provided. As above, this is not a machine learning device.

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